All Oncology News

The FDA has accepted a biologics license application for glofitamab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

Japan has approved durvalumab monotherapy and durvalumab plus tremelimumab for unresectable hepatocellular carcinoma, durvalumab plus tremelimumab and chemotherapy for unresectable, advanced, or recurrent non–small cell lung cancer, and durvalumab plus chemotherapy for curatively unresectable biliary tract cancer.

Joseph A. Sparano, MD, highlights practice-changing clinical trials, novel therapies, the evolving treatment landscape, and unmet needs in the field of breast cancer.

Paul J. Shaughnessy, MD, discusses the unique properties of obecabtagene autoleucel in B-cell acute lymphoblastic leukemia and how findings from the FELIX trial support further research into the benefits of CAR T-cell therapy in patients with hematologic malignancies.

The FDA has granted a fast track designation to BT8009 for use as a monotherapy in adult patients with previously treated locally advanced or metastatic urothelial cancer.

Adding mitazalimab to mFOLFIRINOX led to a 52% objective response rate as frontline therapy in 23 patients with metastatic pancreatic cancer.

Adding the CDK4/6 inhibitor trilaciclib to platinum-based chemotherapy and avelumab maintenance produced an overall response rate comparable to chemotherapy and maintenance avelumab alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Abiraterone acetate granules for oral suspension demonstrated therapeutic equivalence and comparable safety to the original formulation of abiraterone acetate in patients with metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for use with the selective TKI entrectinib. The assay identifies patients with ROS1-positive NSCLC or NTRK fusion–positive solid tumors who do not have a tissue sample available and who may be appropriate for entrectinib treatment.

Electronic health record systems’ design, usability, and interoperability issues can hinder integration and use.

Tumor treating fields plus standard-of-care therapies led to a statistically significant and clinically meaningful improvement in overall survival vs SOC alone in patients with stage IV NSCLC who progressed while on or after platinum chemotherapy, meeting the primary end point of the LUNAR trial.

Patients with hepatocellular carcinoma with microvascular invasion who received FOLFOX through hepatic arterial infusion chemotherapy experienced improved disease-free survival rates compared with those who received no adjuvant treatment.

Ripretinib improved progression-free survival, objective response rate, and overall survival over sunitinib when given as second-line treatment to patients with gastrointestinal stromal tumor harboring mutations in KIT exon 11 and 17/18 only and who received prior imatinib.

Significant and durable transfusion independence was achieved with imetelstat vs placebo in patients with lower-risk myelodysplastic syndromes who were relapsed, refractory, or ineligible for erythropoiesis-stimulating agents, meeting the primary and a key secondary end point of the phase 3 IMerge trial.

A biologics license application has been submitted to the FDA seeking the approval of cosibelimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.

The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.

HPV status has broad applicability across head and neck cancers, whereas the clinical utility of PD-L1 expression remains a more nuanced question.

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors.

The European Medicines Agency has validated an application for the use of trastuzumab deruxtecan for adults with previously treated unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations.

N-803, a novel IL-15 superagonist, in combination with intravesical Bacillus Calmette–Guérin induced an overall response in more than two-thirds of patients with non–muscle invasive bladder cancer.

The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

Ursula A. Matulonis, MD, discusses the novelty of mirvetuximab soravtansine in platinum-resistant ovarian cancer, and how it will expand options for a traditionally difficult-to-treat population.

Max S. Topp, MD, highlights the rationale for studying bispecific antibodies in newly diagnosed diffuse large B-cell lymphoma, how the safety profile of glofitamab plus R-CHOP contributes to its potential for outpatient administration, and where future directions with this research may lead.

Findings from a recent prospective study show promising safety and patient outcomes data for locally advanced and borderline resectable pancreatic cancer treatment using ablative Stereotactic MRI-Guided On-table Adaptive Radiation Therapy, also known as SMART.

The FDA has not sent an action letter regarding the biologics license application for toripalimab in combination with chemotherapy as treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.

Treatment with PDS0101 plus the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa elicited encouraging overall survival data in patients with checkpoint inhibitor–naïve and –refractory advanced human papillomavirus–positive anal, cervical, head and neck, vaginal, and vulvar cancer.

Data concerning the long-term benefit of PARP inhibitors as maintenance therapy for select patients with ovarian cancer in later-line settings have come under fire in 2022 as several agents have failed to demonstrate improvements in OS outcomes.

David L. Saltman MD, PhD, discusses the unique features of the DetermaIO assay, noted the assay’s applications beyond lung cancer, and emphasized that biomarker combinations potentially have greater predictive benefits than single biomarkers.

The past decade has been a time of great progress in the research of Waldenström macroglobulinemia and the care of patients with the rare form of non-Hodgkin lymphoma.